Trial Outcomes & Findings for Study to Evaluate the Safety and Effectiveness of Intravitreal Injections (IVI) of Brolucizumab in Patients With Neovascular Age-related Macular Degeneration (nAMD) (NCT NCT05269966)
NCT ID: NCT05269966
Last Updated: 2025-03-20
Results Overview
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. Treatment-emergent Adverse Events (TEAEs) in this study are defined as AEs suspected to be related to the study drug.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
105 participants
Primary outcome timeframe
Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
Results posted on
2025-03-20
Participant Flow
In case where both eyes were affected, data of only one eye \['study eye'\] was recorded. Selection of the eye to be considered for the purpose of the study \[referred to as 'study eye'\] was as per the Investigator's discretion.
Participant milestones
| Measure |
Brolucizumab
Brolucizumab, formerly known as ESBA1008, is a humanized single-chain Fv (scFv) antibody fragment.
Brolucizumab 6 mg was administered by Intravitreal (IVT) injections as per the Prescribing information (PI) and in line with the treating physician's clinical judgement.
Patients received loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) was performed based on Best Corrected Visual Acuity (BCVA) and Optical Coherence Tomography (OCT) to assess whether the patient required q8w or q12w dosing.
|
|---|---|
|
Overall Study
STARTED
|
105
|
|
Overall Study
COMPLETED
|
95
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Brolucizumab
Brolucizumab, formerly known as ESBA1008, is a humanized single-chain Fv (scFv) antibody fragment.
Brolucizumab 6 mg was administered by Intravitreal (IVT) injections as per the Prescribing information (PI) and in line with the treating physician's clinical judgement.
Patients received loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) was performed based on Best Corrected Visual Acuity (BCVA) and Optical Coherence Tomography (OCT) to assess whether the patient required q8w or q12w dosing.
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Study to Evaluate the Safety and Effectiveness of Intravitreal Injections (IVI) of Brolucizumab in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Baseline characteristics by cohort
| Measure |
Brolucizumab
n=105 Participants
Brolucizumab, formerly known as ESBA1008, is a humanized single-chain Fv (scFv) antibody fragment.
Brolucizumab 6 mg was administered by Intravitreal (IVT) injections as per the Prescribing information (PI) and in line with the treating physician's clinical judgement.
Patients received loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) was performed based on Best Corrected Visual Acuity (BCVA) and Optical Coherence Tomography (OCT) to assess whether the patient required q8w or q12w dosing.
|
|---|---|
|
Age, Continuous
|
67.7 Years
STANDARD_DEVIATION 9.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
105 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
105 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.Population: Full analysis set
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. Treatment-emergent Adverse Events (TEAEs) in this study are defined as AEs suspected to be related to the study drug.
Outcome measures
| Measure |
Brolucizumab
n=105 Participants
Brolucizumab, formerly known as ESBA1008, is a humanized single-chain Fv (scFv) antibody fragment.
Brolucizumab 6 mg was administered by Intravitreal (IVT) injections as per the Prescribing information (PI) and in line with the treating physician's clinical judgement.
Patients received loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) was performed based on Best Corrected Visual Acuity (BCVA) and Optical Coherence Tomography (OCT) to assess whether the patient required q8w or q12w dosing.
|
|---|---|
|
Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.
At least one AE
|
67 Participants
|
|
Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.
At least one Ocular AEs
|
50 Participants
|
|
Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.
At least one Ocular AE in the Study eye
|
45 Participants
|
|
Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.
At least one Ocular AE in the Fellow eye
|
9 Participants
|
|
Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.
Systemic (non-ocular) AEs
|
31 Participants
|
|
Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.
TEAEs
|
3 Participants
|
|
Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.
AEs related to brolucizumab
|
3 Participants
|
|
Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.
Ongoing AEs
|
10 Participants
|
|
Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.
CTCAE grade of AEs - Total
|
67 Participants
|
|
Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.
CTCAE grade of AEs - Mild
|
63 Participants
|
|
Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.
CTCAE grade of AEs - Moderate
|
6 Participants
|
|
Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.
CTCAE grade of AEs - Severe
|
1 Participants
|
|
Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.
CTCAE grade of AEs - Life Threatening
|
0 Participants
|
|
Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.
CTCAE grade of AEs - Death Related to AE
|
0 Participants
|
|
Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.
Serious adverse event
|
0 Participants
|
|
Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.
Serious AEs related to brolucizumab
|
0 Participants
|
|
Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.
AEs Action Taken - Total
|
67 Participants
|
|
Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.
AEs Action Taken - No action taken
|
66 Participants
|
|
Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.
AEs Action Taken - Investigational treatment permanently discontinued due to this adverse event
|
5 Participants
|
|
Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.
Outcome of AEs - Total
|
67 Participants
|
|
Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.
Outcome of AEs - Not Recovered or Not Resolved
|
10 Participants
|
|
Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.
Outcome of AEs - Recovered or resolved
|
61 Participants
|
|
Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.
Outcome of AEs - Recovering or resolving
|
0 Participants
|
|
Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.
Outcome of AEs - Recovered or resolved with sequelae
|
0 Participants
|
|
Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.
Outcome of AEs - Fatal
|
0 Participants
|
|
Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.
Outcome of AEs - Unknown
|
0 Participants
|
|
Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.
AEs leading to discontinuation from the study
|
4 Participants
|
|
Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.
AEs leading to death
|
0 Participants
|
|
Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.
Related AEs leading to death
|
0 Participants
|
PRIMARY outcome
Timeframe: Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.Population: Full analysis set
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. Treatment-emergent Adverse Events (TEAEs) in this study are defined as AEs suspected to be related to the study drug.
Outcome measures
| Measure |
Brolucizumab
n=105 Participants
Brolucizumab, formerly known as ESBA1008, is a humanized single-chain Fv (scFv) antibody fragment.
Brolucizumab 6 mg was administered by Intravitreal (IVT) injections as per the Prescribing information (PI) and in line with the treating physician's clinical judgement.
Patients received loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) was performed based on Best Corrected Visual Acuity (BCVA) and Optical Coherence Tomography (OCT) to assess whether the patient required q8w or q12w dosing.
|
|---|---|
|
Incidence of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab - Ocular AEs - Preferred Term
Patients with at least one TEAE
|
3 Participants
|
|
Incidence of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab - Ocular AEs - Preferred Term
Eye disorders - Total
|
3 Participants
|
|
Incidence of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab - Ocular AEs - Preferred Term
Eye disorders - Vitritis
|
2 Participants
|
|
Incidence of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab - Ocular AEs - Preferred Term
Eye disorders - Retinal vasculitis
|
1 Participants
|
|
Incidence of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab - Ocular AEs - Preferred Term
Eye disorders - Uveitis
|
1 Participants
|
PRIMARY outcome
Timeframe: Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.Population: Full analysis set
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. Treatment-emergent Adverse Events (TEAEs) in this study are defined as AEs suspected to be related to the study drug.
Outcome measures
| Measure |
Brolucizumab
n=105 Participants
Brolucizumab, formerly known as ESBA1008, is a humanized single-chain Fv (scFv) antibody fragment.
Brolucizumab 6 mg was administered by Intravitreal (IVT) injections as per the Prescribing information (PI) and in line with the treating physician's clinical judgement.
Patients received loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) was performed based on Best Corrected Visual Acuity (BCVA) and Optical Coherence Tomography (OCT) to assess whether the patient required q8w or q12w dosing.
|
|---|---|
|
Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab
TEAEs
|
3 Participants
|
|
Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab
Ocular AEs
|
3 Participants
|
|
Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab
Systemic (non-ocular) AEs
|
0 Participants
|
|
Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab
Suspected TEAEs related to the study medication
|
3 Participants
|
|
Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab
Serious TEAEs
|
0 Participants
|
|
Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab
TEAEs leading to death
|
0 Participants
|
|
Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab
TEAEs leading to discontinuation of study
|
2 Participants
|
PRIMARY outcome
Timeframe: Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.Population: Full analysis set
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study.
Outcome measures
| Measure |
Brolucizumab
n=105 Participants
Brolucizumab, formerly known as ESBA1008, is a humanized single-chain Fv (scFv) antibody fragment.
Brolucizumab 6 mg was administered by Intravitreal (IVT) injections as per the Prescribing information (PI) and in line with the treating physician's clinical judgement.
Patients received loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) was performed based on Best Corrected Visual Acuity (BCVA) and Optical Coherence Tomography (OCT) to assess whether the patient required q8w or q12w dosing.
|
|---|---|
|
Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab
Patients with at least one Ocular AEs
|
50 Participants
|
|
Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab
Eye disorders - Total
|
48 Participants
|
|
Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab
Eye disorders - Conjunctival hemorrhage
|
13 Participants
|
|
Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab
Eye disorders - Cataract
|
10 Participants
|
|
Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab
Eye disorders - Vision blurred
|
9 Participants
|
|
Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab
Eye disorders - Ocular hyperemia
|
7 Participants
|
|
Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab
Eye disorders -Lacrimation increased
|
6 Participants
|
|
Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab
Eye disorders - Eye pain
|
4 Participants
|
|
Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab
Eye disorders - Eye pruritus
|
4 Participants
|
|
Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab
Eye disorders - Visual impairment
|
3 Participants
|
|
Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab
Eye disorders - Macular scar
|
2 Participants
|
|
Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab
Eye disorders - Retinal hemorrhage
|
2 Participants
|
|
Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab
Eye disorders -Vitritis
|
2 Participants
|
|
Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab
Eye disorders - Conjunctival hyperemia
|
1 Participants
|
|
Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab
Eye disorders - Eye irritation
|
1 Participants
|
|
Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab
Eye disorders - Retinal pigment epithelial tear
|
1 Participants
|
|
Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab
Eye disorders - Retinal vasculitis
|
1 Participants
|
|
Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab
Eye disorders - Swelling of eyelid
|
1 Participants
|
|
Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab
Eye disorders -Uveitis
|
1 Participants
|
|
Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab
Eye disorders - Vitreous floaters
|
1 Participants
|
|
Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab
Surgical and medical procedures - Cataract operation
|
6 Participants
|
|
Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab
General disorders and administration site conditions - Total
|
3 Participants
|
|
Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab
General disorders and administration site conditions -Injection site pain
|
1 Participants
|
|
Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab
General disorders and administration site conditions - Instillation site lacrimation
|
1 Participants
|
|
Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab
General disorders and administration site conditions -Sensation of foreign body
|
1 Participants
|
|
Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab
Infections and infestations - Conjunctivitis
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 16, Week 56Population: Full analysis set - The full analysis set (FAS) comprises all patients who received at least one IVT injection of study treatment without protocol deviation with impact and with an assessment at the specified timeframe.
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.
Outcome measures
| Measure |
Brolucizumab
n=81 Participants
Brolucizumab, formerly known as ESBA1008, is a humanized single-chain Fv (scFv) antibody fragment.
Brolucizumab 6 mg was administered by Intravitreal (IVT) injections as per the Prescribing information (PI) and in line with the treating physician's clinical judgement.
Patients received loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) was performed based on Best Corrected Visual Acuity (BCVA) and Optical Coherence Tomography (OCT) to assess whether the patient required q8w or q12w dosing.
|
|---|---|
|
Mean Change in Best-Corrected Visual Acuity (BCVA) From Baseline at Week 16 and Week 56 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letters - Study Eye
Week 16
|
10.7 Letters read
Standard Deviation 12.53
|
|
Mean Change in Best-Corrected Visual Acuity (BCVA) From Baseline at Week 16 and Week 56 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letters - Study Eye
Week 56
|
15.3 Letters read
Standard Deviation 13.74
|
SECONDARY outcome
Timeframe: Baseline, Week 16, Week 56Population: Full analysis set - The full analysis set (FAS) comprises all patients who received at least one IVT injection of study treatment without protocol deviation with impact and with an assessment at the specified timeframe.
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.
Outcome measures
| Measure |
Brolucizumab
n=81 Participants
Brolucizumab, formerly known as ESBA1008, is a humanized single-chain Fv (scFv) antibody fragment.
Brolucizumab 6 mg was administered by Intravitreal (IVT) injections as per the Prescribing information (PI) and in line with the treating physician's clinical judgement.
Patients received loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) was performed based on Best Corrected Visual Acuity (BCVA) and Optical Coherence Tomography (OCT) to assess whether the patient required q8w or q12w dosing.
|
|---|---|
|
Change in Best-Corrected Visual Acuity (BCVA) From Baseline at Week 16 and Week 56 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letters - Median - Study Eye
Week 16
|
7.0 Letters read
Interval -16.0 to 70.0
|
|
Change in Best-Corrected Visual Acuity (BCVA) From Baseline at Week 16 and Week 56 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letters - Median - Study Eye
Week 56
|
15.0 Letters read
Interval -29.0 to 70.0
|
SECONDARY outcome
Timeframe: Baseline, Week 16 and Week 56Population: Full analysis set - The full analysis set (FAS) comprises all patients who received at least one IVT injection of study treatment without protocol deviation with impact and with an assessment at the specified timeframe.
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.
Outcome measures
| Measure |
Brolucizumab
n=105 Participants
Brolucizumab, formerly known as ESBA1008, is a humanized single-chain Fv (scFv) antibody fragment.
Brolucizumab 6 mg was administered by Intravitreal (IVT) injections as per the Prescribing information (PI) and in line with the treating physician's clinical judgement.
Patients received loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) was performed based on Best Corrected Visual Acuity (BCVA) and Optical Coherence Tomography (OCT) to assess whether the patient required q8w or q12w dosing.
|
|---|---|
|
Number and Percentage (%) of Participants With Gain in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye
Week 16 - Total Visual Acuity Score (ETDRS letters) Gain ≥ 15 ETDRS letters
|
27 Participants
Interval 17.68 to 35.17
|
|
Number and Percentage (%) of Participants With Gain in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye
Week 16 -Total Visual Acuity Score (ETDRS letters) Gain ≥ 10 ETDRS letters
|
41 Participants
Interval 29.67 to 49.06
|
|
Number and Percentage (%) of Participants With Gain in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye
Week 16 -Total Visual Acuity Score (ETDRS letters) Gain ≥ 5 ETDRS letters
|
79 Participants
Interval 65.86 to 83.14
|
|
Number and Percentage (%) of Participants With Gain in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye
Week 56 - Total Visual Acuity Score (ETDRS letters) Gain ≥ 15 ETDRS letters
|
46 Participants
Interval 34.14 to 53.83
|
|
Number and Percentage (%) of Participants With Gain in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye
Week 56 - Total Visual Acuity Score (ETDRS letters) Gain ≥ 10 ETDRS letters
|
62 Participants
Interval 49.02 to 68.55
|
|
Number and Percentage (%) of Participants With Gain in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye
Week 56 - Total Visual Acuity Score (ETDRS letters) Gain ≥ 5 ETDRS letters
|
78 Participants
Interval 64.83 to 82.32
|
SECONDARY outcome
Timeframe: Baseline, Week 16 and Week 56Population: Full analysis set - The full analysis set (FAS) comprises all patients who received at least one IVT injection of study treatment without protocol deviation with impact and with an assessment at the specified timeframe.
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.
Outcome measures
| Measure |
Brolucizumab
n=105 Participants
Brolucizumab, formerly known as ESBA1008, is a humanized single-chain Fv (scFv) antibody fragment.
Brolucizumab 6 mg was administered by Intravitreal (IVT) injections as per the Prescribing information (PI) and in line with the treating physician's clinical judgement.
Patients received loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) was performed based on Best Corrected Visual Acuity (BCVA) and Optical Coherence Tomography (OCT) to assess whether the patient required q8w or q12w dosing.
|
|---|---|
|
Number and Percentage (%) of Participants With Loss in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye
Week 16 - Total Visual Acuity Score (ETDRS letters) loss ≥ 15 ETDRS letters
|
2 Participants
|
|
Number and Percentage (%) of Participants With Loss in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye
Week 16 -Total Visual Acuity Score (ETDRS letters) loss ≥ 10 ETDRS letters
|
2 Participants
|
|
Number and Percentage (%) of Participants With Loss in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye
Week 16 -Total Visual Acuity Score (ETDRS letters) loss ≥ 5 ETDRS letters
|
3 Participants
|
|
Number and Percentage (%) of Participants With Loss in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye
Week 56 - Total Visual Acuity Score (ETDRS letters) loss ≥ 15 ETDRS letters
|
2 Participants
|
|
Number and Percentage (%) of Participants With Loss in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye
Week 56 - Total Visual Acuity Score (ETDRS letters) loss ≥ 10 ETDRS letters
|
2 Participants
|
|
Number and Percentage (%) of Participants With Loss in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye
Week 56 - Total Visual Acuity Score (ETDRS letters) loss ≥ 5 ETDRS letters
|
3 Participants
|
SECONDARY outcome
Timeframe: Week 56Population: Full analysis set
Characterize the number of anti-VEGF injections during the 56 weeks of treatment with brolucizumab.
Outcome measures
| Measure |
Brolucizumab
n=105 Participants
Brolucizumab, formerly known as ESBA1008, is a humanized single-chain Fv (scFv) antibody fragment.
Brolucizumab 6 mg was administered by Intravitreal (IVT) injections as per the Prescribing information (PI) and in line with the treating physician's clinical judgement.
Patients received loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) was performed based on Best Corrected Visual Acuity (BCVA) and Optical Coherence Tomography (OCT) to assess whether the patient required q8w or q12w dosing.
|
|---|---|
|
Number of Anti-VEGF Injections, During the 56 Weeks of Treatment With Brolucizumab - Study Eye
|
6.2 Injections
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: Week 56Population: Full analysis set
Characterize number of non-injection visits during the 56 weeks of treatment with brolucizumab.
Outcome measures
| Measure |
Brolucizumab
n=105 Participants
Brolucizumab, formerly known as ESBA1008, is a humanized single-chain Fv (scFv) antibody fragment.
Brolucizumab 6 mg was administered by Intravitreal (IVT) injections as per the Prescribing information (PI) and in line with the treating physician's clinical judgement.
Patients received loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) was performed based on Best Corrected Visual Acuity (BCVA) and Optical Coherence Tomography (OCT) to assess whether the patient required q8w or q12w dosing.
|
|---|---|
|
Number of Non-injection Visits During the 56 Weeks of Treatment With Brolucizumab
|
0.2 Visits
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: Week 56Population: Full analysis set
Characterize the total number of visits during the 56 weeks of treatment with brolucizumab.
Outcome measures
| Measure |
Brolucizumab
n=105 Participants
Brolucizumab, formerly known as ESBA1008, is a humanized single-chain Fv (scFv) antibody fragment.
Brolucizumab 6 mg was administered by Intravitreal (IVT) injections as per the Prescribing information (PI) and in line with the treating physician's clinical judgement.
Patients received loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) was performed based on Best Corrected Visual Acuity (BCVA) and Optical Coherence Tomography (OCT) to assess whether the patient required q8w or q12w dosing.
|
|---|---|
|
Total Number of Visits During the 56 Weeks of Treatment With Brolucizumab.
|
6.2 visits
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: Week 56Population: Full analysis set
Outcome measures
| Measure |
Brolucizumab
n=105 Participants
Brolucizumab, formerly known as ESBA1008, is a humanized single-chain Fv (scFv) antibody fragment.
Brolucizumab 6 mg was administered by Intravitreal (IVT) injections as per the Prescribing information (PI) and in line with the treating physician's clinical judgement.
Patients received loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) was performed based on Best Corrected Visual Acuity (BCVA) and Optical Coherence Tomography (OCT) to assess whether the patient required q8w or q12w dosing.
|
|---|---|
|
Number and Percentage (%) of Participants With at Least One Duration of Interval Between Injections ≥ 8 Weeks But <12 Weeks.
|
27 Participants
|
SECONDARY outcome
Timeframe: Week 56Population: Full analysis set
Outcome measures
| Measure |
Brolucizumab
n=105 Participants
Brolucizumab, formerly known as ESBA1008, is a humanized single-chain Fv (scFv) antibody fragment.
Brolucizumab 6 mg was administered by Intravitreal (IVT) injections as per the Prescribing information (PI) and in line with the treating physician's clinical judgement.
Patients received loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) was performed based on Best Corrected Visual Acuity (BCVA) and Optical Coherence Tomography (OCT) to assess whether the patient required q8w or q12w dosing.
|
|---|---|
|
Number and Percentage (%) of Participants With at Least One Duration of Interval Between Injections ≥ 12 Weeks.
At least one duration of interval between injections ≥ 12 weeks
|
74 Participants
|
|
Number and Percentage (%) of Participants With at Least One Duration of Interval Between Injections ≥ 12 Weeks.
q8w dosing
|
27 Participants
|
|
Number and Percentage (%) of Participants With at Least One Duration of Interval Between Injections ≥ 12 Weeks.
q12w dosing
|
74 Participants
|
SECONDARY outcome
Timeframe: Week 16 and Week 56Population: Full analysis set
Estimate effect of brolucizumab on fluid (increased/reduced/unchanged) from baseline to week 16 and week 56 based on Optical Coherence Tomography (SD-OCT) Image Analysis from the central reading center.
Outcome measures
| Measure |
Brolucizumab
n=105 Participants
Brolucizumab, formerly known as ESBA1008, is a humanized single-chain Fv (scFv) antibody fragment.
Brolucizumab 6 mg was administered by Intravitreal (IVT) injections as per the Prescribing information (PI) and in line with the treating physician's clinical judgement.
Patients received loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) was performed based on Best Corrected Visual Acuity (BCVA) and Optical Coherence Tomography (OCT) to assess whether the patient required q8w or q12w dosing.
|
|---|---|
|
Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Absent at Baseline - Study Eye
Week 16 Absent
|
2 Participants
|
|
Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Absent at Baseline - Study Eye
Week 16 Decreased
|
0 Participants
|
|
Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Absent at Baseline - Study Eye
Week 16 Increased
|
0 Participants
|
|
Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Absent at Baseline - Study Eye
Week 56 Absent
|
2 Participants
|
|
Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Absent at Baseline - Study Eye
Week 56 Decreased
|
0 Participants
|
|
Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Absent at Baseline - Study Eye
Week 56 Increased
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 16 and Week 56Population: Full analysis set
Estimate effect of brolucizumab on fluid (increased/reduced/unchanged) from baseline to week 16 and week 56 based on Optical Coherence Tomography (SD-OCT) Image Analysis from the central reading center.
Outcome measures
| Measure |
Brolucizumab
n=105 Participants
Brolucizumab, formerly known as ESBA1008, is a humanized single-chain Fv (scFv) antibody fragment.
Brolucizumab 6 mg was administered by Intravitreal (IVT) injections as per the Prescribing information (PI) and in line with the treating physician's clinical judgement.
Patients received loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) was performed based on Best Corrected Visual Acuity (BCVA) and Optical Coherence Tomography (OCT) to assess whether the patient required q8w or q12w dosing.
|
|---|---|
|
Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Present at Baseline - Study Eye
Week 16 Absent
|
23 Participants
|
|
Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Present at Baseline - Study Eye
Week 16 Decreased
|
54 Participants
|
|
Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Present at Baseline - Study Eye
Week 16 Increased
|
22 Participants
|
|
Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Present at Baseline - Study Eye
Week 56 Absent
|
43 Participants
|
|
Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Present at Baseline - Study Eye
Week 56 Decreased
|
50 Participants
|
|
Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Present at Baseline - Study Eye
Week 56 Increased
|
7 Participants
|
SECONDARY outcome
Timeframe: Week 16 and Week 56Population: Full analysis set
Estimate effect of brolucizumab on fluid from baseline to week 16 and week 56. Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.
Outcome measures
| Measure |
Brolucizumab
n=105 Participants
Brolucizumab, formerly known as ESBA1008, is a humanized single-chain Fv (scFv) antibody fragment.
Brolucizumab 6 mg was administered by Intravitreal (IVT) injections as per the Prescribing information (PI) and in line with the treating physician's clinical judgement.
Patients received loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) was performed based on Best Corrected Visual Acuity (BCVA) and Optical Coherence Tomography (OCT) to assess whether the patient required q8w or q12w dosing.
|
|---|---|
|
Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Absent at Baseline - Study Eye
Week 16 Absent
|
10 Participants
|
|
Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Absent at Baseline - Study Eye
Week 16 Decreased
|
0 Participants
|
|
Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Absent at Baseline - Study Eye
Week 16 Increased
|
0 Participants
|
|
Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Absent at Baseline - Study Eye
Week 56 Absent
|
11 Participants
|
|
Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Absent at Baseline - Study Eye
Week 56 Decreased
|
0 Participants
|
|
Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Absent at Baseline - Study Eye
Week 56 Increased
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 16 and Week 56Population: Full analysis set
Estimate effect of brolucizumab on fluid from baseline to week 16 and week 56. Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.
Outcome measures
| Measure |
Brolucizumab
n=105 Participants
Brolucizumab, formerly known as ESBA1008, is a humanized single-chain Fv (scFv) antibody fragment.
Brolucizumab 6 mg was administered by Intravitreal (IVT) injections as per the Prescribing information (PI) and in line with the treating physician's clinical judgement.
Patients received loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) was performed based on Best Corrected Visual Acuity (BCVA) and Optical Coherence Tomography (OCT) to assess whether the patient required q8w or q12w dosing.
|
|---|---|
|
Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Present at Baseline - Study Eye
Week 16 Absent
|
20 Participants
|
|
Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Present at Baseline - Study Eye
Week 16 Decreased
|
57 Participants
|
|
Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Present at Baseline - Study Eye
Week 16 Increased
|
14 Participants
|
|
Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Present at Baseline - Study Eye
Week 56 Absent
|
30 Participants
|
|
Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Present at Baseline - Study Eye
Week 56 Decreased
|
57 Participants
|
|
Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Present at Baseline - Study Eye
Week 56 Increased
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 16 and Week 56Population: Full analysis set
Estimate effect of brolucizumab on central subfield thickness (CST) from baseline to week 16 and week 56 as measured by Optical Coherence Tomography (in µm).
Outcome measures
| Measure |
Brolucizumab
n=105 Participants
Brolucizumab, formerly known as ESBA1008, is a humanized single-chain Fv (scFv) antibody fragment.
Brolucizumab 6 mg was administered by Intravitreal (IVT) injections as per the Prescribing information (PI) and in line with the treating physician's clinical judgement.
Patients received loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) was performed based on Best Corrected Visual Acuity (BCVA) and Optical Coherence Tomography (OCT) to assess whether the patient required q8w or q12w dosing.
|
|---|---|
|
Estimate CST Change From Baseline at Week 16 and Week 56 - Mean - Study Eye
Week 16
|
-106.9 μm
Standard Deviation 129.14
|
|
Estimate CST Change From Baseline at Week 16 and Week 56 - Mean - Study Eye
Week 56
|
-103.1 μm
Standard Deviation 152.64
|
SECONDARY outcome
Timeframe: Baseline, Week 16 and Week 56Population: Full analysis set
Estimate effect of brolucizumab on central subfield thickness (CST) from baseline to week 16 and week 56 as measured by Optical Coherence Tomography (in µm).
Outcome measures
| Measure |
Brolucizumab
n=105 Participants
Brolucizumab, formerly known as ESBA1008, is a humanized single-chain Fv (scFv) antibody fragment.
Brolucizumab 6 mg was administered by Intravitreal (IVT) injections as per the Prescribing information (PI) and in line with the treating physician's clinical judgement.
Patients received loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) was performed based on Best Corrected Visual Acuity (BCVA) and Optical Coherence Tomography (OCT) to assess whether the patient required q8w or q12w dosing.
|
|---|---|
|
Estimate CST Change From Baseline at Week 16 and Week 56 - Median - Study Eye
Week 16
|
-60.0 μm
Interval -923.0 to 84.0
|
|
Estimate CST Change From Baseline at Week 16 and Week 56 - Median - Study Eye
Week 56
|
-66.5 μm
Interval -902.0 to 369.0
|
Adverse Events
Brolucizumab
Serious events: 0 serious events
Other events: 67 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Brolucizumab
n=105 participants at risk
Brolucizumab, formerly known as ESBA1008, is a humanized single-chain Fv (scFv) antibody fragment.
Brolucizumab 6 mg was administered by Intravitreal (IVT) injections as per the Prescribing information (PI) and in line with the treating physician's clinical judgement.
Patients received loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) was performed based on Best Corrected Visual Acuity (BCVA) and Optical Coherence Tomography (OCT) to assess whether the patient required q8w or q12w dosing.
|
|---|---|
|
Eye disorders
Cataract- Fellow eye
|
3.8%
4/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Eye disorders
Cataract- Study eye
|
7.6%
8/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Eye disorders
Conjunctival haemorrhage- Study eye
|
12.4%
13/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Eye disorders
Conjunctival hyperaemia- Study eye
|
0.95%
1/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Eye disorders
Eye irritation- Study eye
|
0.95%
1/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Eye disorders
Eye pain- Study eye
|
3.8%
4/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Eye disorders
Eye pruritus- Study eye
|
3.8%
4/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Eye disorders
Lacrimation increased- Fellow eye
|
1.9%
2/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Eye disorders
Lacrimation increased- Study eye
|
3.8%
4/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Eye disorders
Macular scar- Study eye
|
1.9%
2/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Eye disorders
Ocular hyperaemia- Study eye
|
6.7%
7/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Eye disorders
Retinal haemorrhage- Study eye
|
1.9%
2/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Eye disorders
Retinal pigment epithelial tear- Study eye
|
0.95%
1/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Eye disorders
Retinal vasculitis- Study eye
|
0.95%
1/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Eye disorders
Swelling of eyelid- Study eye
|
0.95%
1/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Eye disorders
Uveitis- Study eye
|
0.95%
1/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Eye disorders
Vision blurred- Fellow eye
|
3.8%
4/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Eye disorders
Vision blurred- Study eye
|
5.7%
6/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Eye disorders
Visual impairment- Study eye
|
2.9%
3/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Eye disorders
Vitreous floaters- Study eye
|
0.95%
1/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Eye disorders
Vitritis- Study eye
|
1.9%
2/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.9%
3/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.95%
1/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Gastrointestinal disorders
Nausea
|
1.9%
2/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
2/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
General disorders
Asthenia
|
0.95%
1/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
General disorders
Injection site pain- Study eye
|
0.95%
1/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
General disorders
Instillation site lacrimation- Study eye
|
0.95%
1/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
General disorders
Pain
|
0.95%
1/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
General disorders
Pyrexia
|
12.4%
13/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
General disorders
Sensation of foreign body- Fellow eye
|
0.95%
1/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Infections and infestations
Conjunctivitis- Study eye
|
0.95%
1/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
0.95%
1/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Infections and infestations
Viral infection
|
0.95%
1/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Investigations
Blood pressure increased
|
1.9%
2/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.95%
1/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.9%
2/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.95%
1/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.95%
1/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Nervous system disorders
Headache
|
7.6%
8/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
2/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.9%
2/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Surgical and medical procedures
Cataract operation- Fellow eye
|
2.9%
3/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
|
Surgical and medical procedures
Cataract operation- Study eye
|
2.9%
3/105 • Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER